Trial Outcomes & Findings for Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib (NCT NCT00101660)
NCT ID: NCT00101660
Last Updated: 2012-03-02
Results Overview
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
387 participants
Primary outcome timeframe
2 years
Results posted on
2012-03-02
Participant Flow
Participant milestones
| Measure |
Imatinib-intolerant
Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
|
Imatinib-resistant
Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm\^3; an absolute increase in WBC by more than 50,000/mm\^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
288
|
|
Overall Study
COMPLETED
|
99
|
288
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
Baseline characteristics by cohort
| Measure |
Imatinib-intolerant
n=99 Participants
Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
|
Imatinib-resistant
n=288 Participants
Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm\^3; an absolute increase in WBC by more than 50,000/mm\^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
|
Total
n=387 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
54.6 Years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
55.7 Years
STANDARD_DEVIATION 13.5 • n=107 Participants
|
55.4 Years
STANDARD_DEVIATION 13.3 • n=206 Participants
|
|
Age, Customized
Between 21 and 45 years
|
25 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Age, Customized
Between 46 and 65 years
|
55 Participants
n=99 Participants
|
131 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
|
Age, Customized
Between 66 and 75 years
|
17 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Age, Customized
> 75 years
|
2 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
196 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
191 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
93 Participants
n=99 Participants
|
252 Participants
n=107 Participants
|
345 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
2 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Performance Status - Eastern Cooperative Oncology Group Scale (ECOG) Score
0
|
71 Participants
n=99 Participants
|
205 Participants
n=107 Participants
|
276 Participants
n=206 Participants
|
|
Performance Status - Eastern Cooperative Oncology Group Scale (ECOG) Score
1
|
28 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Performance Status - Eastern Cooperative Oncology Group Scale (ECOG) Score
2
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Performance Status - Eastern Cooperative Oncology Group Scale (ECOG) Score
3
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Performance Status - Eastern Cooperative Oncology Group Scale (ECOG) Score
4
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Performance Status - Eastern Cooperative Oncology Group Scale (ECOG) Score
5
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Performance Status - Eastern Cooperative Oncology Group Scale (ECOG) Score
Not reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Functional Assessment of Cancer Therapy-General (FACT-G)
Total FACT-G
|
81.1 Units on a scale
STANDARD_DEVIATION 14.4 • n=99 Participants
|
82.4 Units on a scale
STANDARD_DEVIATION 13.1 • n=107 Participants
|
82.1 Units on a scale
STANDARD_DEVIATION 13.4 • n=206 Participants
|
|
Functional Assessment of Cancer Therapy-General (FACT-G)
PWB
|
22.0 Units on a scale
STANDARD_DEVIATION 5.1 • n=99 Participants
|
21.6 Units on a scale
STANDARD_DEVIATION 5.2 • n=107 Participants
|
21.7 Units on a scale
STANDARD_DEVIATION 5.2 • n=206 Participants
|
|
Functional Assessment of Cancer Therapy-General (FACT-G)
SWB
|
23.0 Units on a scale
STANDARD_DEVIATION 4.4 • n=99 Participants
|
23.0 Units on a scale
STANDARD_DEVIATION 4.5 • n=107 Participants
|
23.0 Units on a scale
STANDARD_DEVIATION 4.4 • n=206 Participants
|
|
Functional Assessment of Cancer Therapy-General (FACT-G)
EWB
|
17.3 Units on a scale
STANDARD_DEVIATION 4.0 • n=99 Participants
|
18.4 Units on a scale
STANDARD_DEVIATION 3.7 • n=107 Participants
|
18.1 Units on a scale
STANDARD_DEVIATION 3.8 • n=206 Participants
|
|
Functional Assessment of Cancer Therapy-General (FACT-G)
FWB
|
18.7 Units on a scale
STANDARD_DEVIATION 5.5 • n=99 Participants
|
19.6 Units on a scale
STANDARD_DEVIATION 5.6 • n=107 Participants
|
19.4 Units on a scale
STANDARD_DEVIATION 5.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All imatinib-resistant participants who received treatment.
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.
Outcome measures
| Measure |
Dasatinib, 70 mg, Twice Daily (BID)
n=288 Participants
Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
|
|---|---|
|
Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)
|
159 Participants
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: All imatinib-intolerant participants who received treatment.
Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.
Outcome measures
| Measure |
Dasatinib, 70 mg, Twice Daily (BID)
n=99 Participants
Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
|
|---|---|
|
Number of Imatinib-intolerant Participants With MCyR
|
81 Participants
|
SECONDARY outcome
Timeframe: 12 and 24 MonthsPopulation: Population is limited to responders (those who acheived MCyR) who were also assessed for duration of MCyR.
Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases.
Outcome measures
| Measure |
Dasatinib, 70 mg, Twice Daily (BID)
n=240 Participants
Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
|
|---|---|
|
Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months
Imatinib-intolerant group: 12 months (n=81)
|
98.5 Percentage of participants
|
|
Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months
Imatinib-intolerant group: 24 months (n=81)
|
96.7 Percentage of participants
|
|
Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months
Imatinib-resistant group: 12 months (n=159)
|
93.7 Percentage of participants
|
|
Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months
Imatinib-resistant group: 24 months (n=159)
|
83.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (within 4 weeks of Day 1) and every 12 weeksPopulation: Population is limited to responders (those who acheived MCyR) only
MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.
Outcome measures
| Measure |
Dasatinib, 70 mg, Twice Daily (BID)
n=240 Participants
Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
|
|---|---|
|
Median Time From First Dosing Date to Date of MCyR
Imatinib-resistant
|
2.92 Months
Interval 0.95 to 22.37
|
|
Median Time From First Dosing Date to Date of MCyR
Imatinib-intolerant
|
2.79 Months
Interval 0.79 to 16.39
|
SECONDARY outcome
Timeframe: Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-studyPopulation: All participants who received treatment.
CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \<450,000/mm\^3; no blasts or promyelocytes in peripheral blood; \<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Outcome measures
| Measure |
Dasatinib, 70 mg, Twice Daily (BID)
n=387 Participants
Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
|
|---|---|
|
Number of Participants With Complete Hematologic Response (CHR)
Imatinib-intolerant (n=99)
|
93 Participants
|
|
Number of Participants With Complete Hematologic Response (CHR)
Imatinib-resistant (n=288)
|
259 Participants
|
SECONDARY outcome
Timeframe: 12 and 24 monthsPopulation: Population limited to responders (those achieving CHR) only
Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \< 450,000/mm\^3; no blasts or promyelocytes in peripheral blood; \<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Outcome measures
| Measure |
Dasatinib, 70 mg, Twice Daily (BID)
n=352 Participants
Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
|
|---|---|
|
Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months
Imatinib-intolerant: 12 months (n=93)
|
97.7 Percentage of participants
|
|
Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months
Imatinib-intolerant: 24 months (n=93)
|
93.5 Percentage of participants
|
|
Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months
Imatinib-resistant: 12 months (n=259)
|
90.4 Percentage of participants
|
|
Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months
Imatinib-resistant: 24 months (n=259)
|
78.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-studyPopulation: Population limited to responders (those achieving CHR) only
CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \<450,000/mm\^3; no blasts or promyelocytes in peripheral blood; \<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Outcome measures
| Measure |
Dasatinib, 70 mg, Twice Daily (BID)
n=352 Participants
Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
|
|---|---|
|
Median Time From First Dosing Until CHR
Imatinib-intolerant (n=93)
|
0.49 Months
Interval 0.46 to 3.78
|
|
Median Time From First Dosing Until CHR
Imatinib-resistant (n=259)
|
0.53 Months
Interval 0.46 to 12.39
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: All participants who received treatment.
MMR is defined as ≤3 log reduction in BCR-ABL levels from the standardized baseline value of BCR-ABL:Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL:Control gene ratio by the lab-specific conversion factor.
Outcome measures
| Measure |
Dasatinib, 70 mg, Twice Daily (BID)
n=387 Participants
Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
|
|---|---|
|
Number of Participants With Major Molecular Response (MMR)
Imatinib-intolerant (n=99)
|
73 Participants
|
|
Number of Participants With Major Molecular Response (MMR)
Imatinib-resistant (n=288)
|
102 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.Population: Number of participants with assessments at baseline and timepoint
Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, \& FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics.
Outcome measures
| Measure |
Dasatinib, 70 mg, Twice Daily (BID)
n=321 Participants
Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
|
|---|---|
|
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Imatinib-intolerant: Total FACT-G (n=80)
|
34 Participants
|
|
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Imatinib-intolerant: PWB (n=80)
|
36 Participants
|
|
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Imatinib-intolerant: SWB (n=80)
|
33 Participants
|
|
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Imatinib-intolerant: EWB (n=80)
|
40 Participants
|
|
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Imatinib-intolerant: FWB (n=80)
|
32 Participants
|
|
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Imatinib-resistant: Total FACT-G (n=241)
|
107 Participants
|
|
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Imatinib-resistant: PWB (n=241)
|
103 Participants
|
|
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Imatinib-resistant: SWB (n=241)
|
94 Participants
|
|
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Imatinib-resistant: EWB (n=241)
|
107 Participants
|
|
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Imatinib-resistant: FWB (n=241)
|
89 Participants
|
SECONDARY outcome
Timeframe: Continuously, from baseline through 2 yearsPopulation: All imitanib-intolerant participants who received treatment.
AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
Outcome measures
| Measure |
Dasatinib, 70 mg, Twice Daily (BID)
n=99 Participants
Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
|
|---|---|
|
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
Grade 3-4 thrombocytopenia
|
32 Participants
|
|
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
Drug-related AEs
|
97 Participants
|
|
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
Death within 30 days of last dose
|
0 Participants
|
|
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
Deaths
|
0 Participants
|
|
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
On-study AEs leading to discontinuation
|
16 Participants
|
|
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
SAEs
|
48 Participants
|
|
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
Grade 3-4 neutropenia
|
39 Participants
|
|
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
Any AE
|
98 Participants
|
SECONDARY outcome
Timeframe: Continuously, from baseline through 2 yearsPopulation: All imitanib-resistant participants who received treatment.
AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
Outcome measures
| Measure |
Dasatinib, 70 mg, Twice Daily (BID)
n=288 Participants
Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
|
|---|---|
|
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
Drug-related AEs
|
281 Participants
|
|
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
Death within 30 days of last dose
|
8 Participants
|
|
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
Deaths
|
19 Participants
|
|
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
On-study AEs leading to Discontinuation
|
53 Participants
|
|
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
SAEs
|
146 Participants
|
|
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
Grade 3-4 thrombocytopenia
|
156 Participants
|
|
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
Grade 3-4 neutropenia
|
154 Participants
|
|
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
Any AE
|
288 Participants
|
SECONDARY outcome
Timeframe: Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose.Population: No study-specific PK analyses were planned for this report.
Blood samples were collected for PK to be included in separate population PK analyses.
Outcome measures
Outcome data not reported
Adverse Events
Intolerant
Serious events: 48 serious events
Other events: 96 other events
Deaths: 0 deaths
Resistant
Serious events: 146 serious events
Other events: 287 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intolerant
n=99 participants at risk
|
Resistant
n=288 participants at risk
|
|---|---|---|
|
Investigations
LIPASE
|
1.0%
1/99
|
0.00%
0/288
|
|
Investigations
PROLONGED
|
0.00%
0/99
|
0.00%
0/288
|
|
Investigations
PLEUROSCOPY
|
0.00%
0/99
|
0.35%
1/288
|
|
Investigations
PLATELET COUNT
|
0.00%
0/99
|
0.69%
2/288
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/99
|
0.35%
1/288
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/99
|
0.69%
2/288
|
|
Investigations
BLOOD CULTURE POSITIVE
|
0.00%
0/99
|
0.35%
1/288
|
|
Investigations
BLOOD CREATINE INCREASED
|
0.00%
0/99
|
0.35%
1/288
|
|
Investigations
PLATELET COUNT DECREASED
|
1.0%
1/99
|
0.69%
2/288
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.00%
0/99
|
0.35%
1/288
|
|
Investigations
BIOPSY BONE MARROW ABNORMAL
|
0.00%
0/99
|
0.35%
1/288
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
1.0%
1/99
|
0.00%
0/288
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
1.0%
1/99
|
0.00%
0/288
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
1.0%
1/99
|
0.00%
0/288
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/99
|
0.35%
1/288
|
|
Investigations
ELECTROCARDIOGRAM QT CORRECTED INTERVAL
|
0.00%
0/99
|
0.00%
0/288
|
|
Cardiac disorders
CYANOSIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Cardiac disorders
NODAL RHYTHM
|
1.0%
1/99
|
0.00%
0/288
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/99
|
0.35%
1/288
|
|
Cardiac disorders
PERICARDITIS
|
1.0%
1/99
|
0.35%
1/288
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.00%
0/99
|
0.35%
1/288
|
|
Cardiac disorders
ANGINA PECTORIS
|
2.0%
2/99
|
0.35%
1/288
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/99
|
0.35%
1/288
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.0%
1/99
|
0.69%
2/288
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.0%
1/99
|
2.4%
7/288
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/99
|
0.35%
1/288
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.0%
1/99
|
1.0%
3/288
|
|
Cardiac disorders
DIASTOLIC DYSFUNCTION
|
1.0%
1/99
|
0.35%
1/288
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.0%
1/99
|
0.00%
0/288
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
0.00%
0/99
|
0.35%
1/288
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/99
|
0.35%
1/288
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/99
|
0.35%
1/288
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
1.0%
1/99
|
0.00%
0/288
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
1.0%
1/99
|
0.00%
0/288
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.00%
0/99
|
0.35%
1/288
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
5.1%
5/99
|
3.1%
9/288
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/99
|
0.69%
2/288
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
2.0%
2/99
|
0.35%
1/288
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/99
|
0.35%
1/288
|
|
Vascular disorders
EMBOLISM
|
1.0%
1/99
|
0.00%
0/288
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/99
|
0.69%
2/288
|
|
Vascular disorders
HYPERTENSION
|
1.0%
1/99
|
0.35%
1/288
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
1.0%
1/99
|
0.00%
0/288
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.00%
0/99
|
0.35%
1/288
|
|
Endocrine disorders
GOITRE
|
0.00%
0/99
|
0.35%
1/288
|
|
Psychiatric disorders
DEPRESSION
|
1.0%
1/99
|
0.00%
0/288
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
1.0%
1/99
|
0.35%
1/288
|
|
Immune system disorders
HYPERSENSITIVITY
|
1.0%
1/99
|
0.69%
2/288
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/99
|
0.35%
1/288
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/99
|
0.35%
1/288
|
|
Nervous system disorders
HEADACHE
|
1.0%
1/99
|
0.35%
1/288
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/99
|
0.35%
1/288
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/99
|
0.69%
2/288
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
NAUSEA
|
1.0%
1/99
|
0.69%
2/288
|
|
Gastrointestinal disorders
COLITIS
|
1.0%
1/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
MELAENA
|
1.0%
1/99
|
0.00%
0/288
|
|
Gastrointestinal disorders
VOMITING
|
1.0%
1/99
|
1.0%
3/288
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.0%
2/99
|
3.5%
10/288
|
|
Gastrointestinal disorders
ENTERITIS
|
1.0%
1/99
|
0.00%
0/288
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
GINGIVITIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
PANCREATITIS
|
1.0%
1/99
|
0.00%
0/288
|
|
Gastrointestinal disorders
PERIODONTITIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/99
|
1.4%
4/288
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/99
|
0.69%
2/288
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.0%
1/99
|
0.00%
0/288
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
1.0%
1/99
|
0.00%
0/288
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/99
|
1.4%
4/288
|
|
Gastrointestinal disorders
INGUINAL HERNIA, OBSTRUCTIVE
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
ABDOMINAL STRANGULATED HERNIA
|
0.00%
0/99
|
0.69%
2/288
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/99
|
0.35%
1/288
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/99
|
0.35%
1/288
|
|
Ear and labyrinth disorders
EAR HAEMORRHAGE
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
INFECTION
|
0.00%
0/99
|
1.0%
3/288
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
PNEUMONIA
|
5.1%
5/99
|
3.8%
11/288
|
|
Infections and infestations
BRONCHITIS
|
1.0%
1/99
|
1.4%
4/288
|
|
Infections and infestations
CELLULITIS
|
2.0%
2/99
|
1.4%
4/288
|
|
Infections and infestations
APPENDICITIS
|
1.0%
1/99
|
0.00%
0/288
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/99
|
0.69%
2/288
|
|
Infections and infestations
PNEUMONIA FUNGAL
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
FEBRILE INFECTION
|
1.0%
1/99
|
0.00%
0/288
|
|
Infections and infestations
VIRAL PHARYNGITIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
CYTOMEGALOVIRUS COLITIS
|
1.0%
1/99
|
0.00%
0/288
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/99
|
0.35%
1/288
|
|
Infections and infestations
PHARYNGOLARYNGEAL ABSCESS
|
1.0%
1/99
|
0.00%
0/288
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
1.0%
1/99
|
0.00%
0/288
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECI PNEUMONIA
|
0.00%
0/99
|
0.69%
2/288
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.0%
1/99
|
0.00%
0/288
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.0%
1/99
|
0.35%
1/288
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/99
|
0.35%
1/288
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.0%
1/99
|
1.4%
4/288
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/99
|
0.69%
2/288
|
|
Renal and urinary disorders
GLOMERULONEPHROPATHY
|
0.00%
0/99
|
0.35%
1/288
|
|
Surgical and medical procedures
HYSTERECTOMY
|
0.00%
0/99
|
0.35%
1/288
|
|
Surgical and medical procedures
BONE MARROW TRANSPLANT
|
0.00%
0/99
|
0.69%
2/288
|
|
Surgical and medical procedures
CORONARY ARTERIAL STENT INSERTION
|
0.00%
0/99
|
0.35%
1/288
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.00%
0/99
|
0.35%
1/288
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.0%
1/99
|
1.0%
3/288
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/99
|
0.35%
1/288
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
1.0%
1/99
|
0.00%
0/288
|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.0%
2/99
|
2.1%
6/288
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/99
|
0.35%
1/288
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/99
|
0.69%
2/288
|
|
Blood and lymphatic system disorders
SPLENOMEGALY
|
0.00%
0/99
|
0.35%
1/288
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/99
|
2.8%
8/288
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
2.0%
2/99
|
2.4%
7/288
|
|
Skin and subcutaneous tissue disorders
ACNE
|
1.0%
1/99
|
0.00%
0/288
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/99
|
0.35%
1/288
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/99
|
0.35%
1/288
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/99
|
0.35%
1/288
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
0.00%
0/99
|
0.35%
1/288
|
|
Skin and subcutaneous tissue disorders
SKIN NECROSIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Reproductive system and breast disorders
UTERINE HAEMORRHAGE
|
0.00%
0/99
|
0.35%
1/288
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/99
|
0.35%
1/288
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/99
|
0.35%
1/288
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/99
|
0.35%
1/288
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/99
|
0.35%
1/288
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.00%
0/99
|
0.35%
1/288
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/99
|
0.35%
1/288
|
|
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
|
0.00%
0/99
|
0.35%
1/288
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/99
|
1.0%
3/288
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/99
|
0.69%
2/288
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/99
|
0.69%
2/288
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
1.0%
1/99
|
0.00%
0/288
|
|
Respiratory, thoracic and mediastinal disorders
STRIDOR
|
1.0%
1/99
|
0.00%
0/288
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
8.1%
8/99
|
5.2%
15/288
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
1.0%
1/99
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
CHYLOTHORAX
|
0.00%
0/99
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
1.0%
1/99
|
0.69%
2/288
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/99
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/99
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL DISORDER
|
0.00%
0/99
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
16.2%
16/99
|
11.1%
32/288
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
1.0%
1/99
|
0.00%
0/288
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
1.0%
1/99
|
1.7%
5/288
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.0%
1/99
|
0.00%
0/288
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
1.0%
1/99
|
0.00%
0/288
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/99
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
1.0%
1/99
|
0.00%
0/288
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM DISORDER
|
0.00%
0/99
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
3.0%
3/99
|
0.00%
0/288
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/99
|
0.35%
1/288
|
|
General disorders
PAIN
|
0.00%
0/99
|
0.35%
1/288
|
|
General disorders
DEATH
|
0.00%
0/99
|
0.35%
1/288
|
|
General disorders
FATIGUE
|
0.00%
0/99
|
1.0%
3/288
|
|
General disorders
MALAISE
|
1.0%
1/99
|
0.35%
1/288
|
|
General disorders
PYREXIA
|
3.0%
3/99
|
9.0%
26/288
|
|
General disorders
ASTHENIA
|
0.00%
0/99
|
0.35%
1/288
|
|
General disorders
CHEST PAIN
|
1.0%
1/99
|
0.69%
2/288
|
|
General disorders
ADVERSE EVENT
|
1.0%
1/99
|
0.00%
0/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASIS
|
0.00%
0/99
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN CANCER
|
1.0%
1/99
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
1.0%
1/99
|
0.00%
0/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
0.00%
0/99
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEIOMYOSARCOMA
|
0.00%
0/99
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/99
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
1.0%
1/99
|
0.69%
2/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.00%
0/99
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC MYELOID LEUKAEMIA
|
0.00%
0/99
|
1.7%
5/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC LYMPHOCYTIC LEUKAEMIA
|
1.0%
1/99
|
0.00%
0/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/99
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC SQUAMOUS CELL CARCINOMA
|
0.00%
0/99
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLAST CRISIS IN MYELOGENOUS LEUKAEMIA
|
0.00%
0/99
|
0.35%
1/288
|
Other adverse events
| Measure |
Intolerant
n=99 participants at risk
|
Resistant
n=288 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
TOOTHACHE
|
3.0%
3/99
|
5.2%
15/288
|
|
Gastrointestinal disorders
FLATULENCE
|
9.1%
9/99
|
6.2%
18/288
|
|
Gastrointestinal disorders
STOMATITIS
|
3.0%
3/99
|
5.2%
15/288
|
|
Gastrointestinal disorders
CONSTIPATION
|
8.1%
8/99
|
18.8%
54/288
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
11.1%
11/99
|
5.9%
17/288
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
17.2%
17/99
|
16.3%
47/288
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
2.0%
2/99
|
5.2%
15/288
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
9.1%
9/99
|
9.4%
27/288
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
14.1%
14/99
|
12.5%
36/288
|
|
Infections and infestations
SINUSITIS
|
8.1%
8/99
|
5.9%
17/288
|
|
Infections and infestations
BRONCHITIS
|
8.1%
8/99
|
8.0%
23/288
|
|
Infections and infestations
ORAL HERPES
|
4.0%
4/99
|
8.3%
24/288
|
|
Infections and infestations
NASOPHARYNGITIS
|
17.2%
17/99
|
18.4%
53/288
|
|
Infections and infestations
URINARY TRACT INFECTION
|
4.0%
4/99
|
6.6%
19/288
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
19.2%
19/99
|
12.5%
36/288
|
|
Metabolism and nutrition disorders
ANOREXIA
|
16.2%
16/99
|
18.1%
52/288
|
|
Blood and lymphatic system disorders
ANAEMIA
|
12.1%
12/99
|
11.5%
33/288
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
16.2%
16/99
|
18.1%
52/288
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
12.1%
12/99
|
23.3%
67/288
|
|
Skin and subcutaneous tissue disorders
ACNE
|
12.1%
12/99
|
5.9%
17/288
|
|
Skin and subcutaneous tissue disorders
RASH
|
43.4%
43/99
|
35.8%
103/288
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
15.2%
15/99
|
8.3%
24/288
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
9.1%
9/99
|
6.2%
18/288
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
11.1%
11/99
|
6.6%
19/288
|
|
Eye disorders
EYELID OEDEMA
|
5.1%
5/99
|
2.1%
6/288
|
|
Eye disorders
VISION BLURRED
|
8.1%
8/99
|
4.2%
12/288
|
|
Investigations
WEIGHT DECREASED
|
12.1%
12/99
|
13.5%
39/288
|
|
Investigations
WEIGHT INCREASED
|
10.1%
10/99
|
10.4%
30/288
|
|
Cardiac disorders
PALPITATIONS
|
6.1%
6/99
|
5.6%
16/288
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
5.1%
5/99
|
4.5%
13/288
|
|
Vascular disorders
FLUSHING
|
9.1%
9/99
|
4.9%
14/288
|
|
Vascular disorders
HOT FLUSH
|
5.1%
5/99
|
4.9%
14/288
|
|
Vascular disorders
HYPERTENSION
|
9.1%
9/99
|
6.6%
19/288
|
|
Psychiatric disorders
ANXIETY
|
6.1%
6/99
|
5.9%
17/288
|
|
Psychiatric disorders
INSOMNIA
|
14.1%
14/99
|
11.5%
33/288
|
|
Psychiatric disorders
DEPRESSION
|
10.1%
10/99
|
6.9%
20/288
|
|
Nervous system disorders
HEADACHE
|
49.5%
49/99
|
44.4%
128/288
|
|
Nervous system disorders
DIZZINESS
|
17.2%
17/99
|
19.4%
56/288
|
|
Nervous system disorders
DYSGEUSIA
|
5.1%
5/99
|
3.5%
10/288
|
|
Nervous system disorders
PARAESTHESIA
|
7.1%
7/99
|
11.5%
33/288
|
|
Gastrointestinal disorders
NAUSEA
|
40.4%
40/99
|
37.5%
108/288
|
|
Gastrointestinal disorders
COLITIS
|
5.1%
5/99
|
2.1%
6/288
|
|
Gastrointestinal disorders
VOMITING
|
17.2%
17/99
|
22.2%
64/288
|
|
Gastrointestinal disorders
DIARRHOEA
|
44.4%
44/99
|
53.1%
153/288
|
|
Gastrointestinal disorders
DYSPEPSIA
|
13.1%
13/99
|
6.6%
19/288
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
18.2%
18/99
|
12.5%
36/288
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
5.1%
5/99
|
3.5%
10/288
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
9.1%
9/99
|
6.2%
18/288
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
7.1%
7/99
|
11.8%
34/288
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
2.0%
2/99
|
5.9%
17/288
|
|
Skin and subcutaneous tissue disorders
PERIORBITAL OEDEMA
|
13.1%
13/99
|
9.7%
28/288
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
7.1%
7/99
|
3.1%
9/288
|
|
Injury, poisoning and procedural complications
CONTUSION
|
5.1%
5/99
|
7.3%
21/288
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
19.2%
19/99
|
17.0%
49/288
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
19.2%
19/99
|
18.4%
53/288
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
10.1%
10/99
|
16.7%
48/288
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
4.0%
4/99
|
8.3%
24/288
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
15.2%
15/99
|
29.9%
86/288
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
10.1%
10/99
|
9.4%
27/288
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
18.2%
18/99
|
20.1%
58/288
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
12.1%
12/99
|
9.4%
27/288
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.1%
5/99
|
5.9%
17/288
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
36.4%
36/99
|
38.2%
110/288
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
46.5%
46/99
|
44.4%
128/288
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
5.1%
5/99
|
3.1%
9/288
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
5.1%
5/99
|
2.4%
7/288
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
3.0%
3/99
|
9.4%
27/288
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
5.1%
5/99
|
3.1%
9/288
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
37.4%
37/99
|
31.2%
90/288
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
5.1%
5/99
|
7.3%
21/288
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
14.1%
14/99
|
14.6%
42/288
|
|
General disorders
PAIN
|
6.1%
6/99
|
7.3%
21/288
|
|
General disorders
CHILLS
|
10.1%
10/99
|
10.8%
31/288
|
|
General disorders
OEDEMA
|
2.0%
2/99
|
5.2%
15/288
|
|
General disorders
FATIGUE
|
48.5%
48/99
|
47.2%
136/288
|
|
General disorders
PYREXIA
|
33.3%
33/99
|
36.1%
104/288
|
|
General disorders
ASTHENIA
|
19.2%
19/99
|
20.1%
58/288
|
|
General disorders
CHEST PAIN
|
17.2%
17/99
|
12.2%
35/288
|
|
General disorders
CHEST DISCOMFORT
|
10.1%
10/99
|
6.6%
19/288
|
|
General disorders
OEDEMA PERIPHERAL
|
24.2%
24/99
|
26.0%
75/288
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
3.0%
3/99
|
6.6%
19/288
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER